Deep Neuromuscular Blockade in Strabismus Surgery

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05882643

Collaborator

(none)

204

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if inducing a moderate or greater neuromuscular block (TOF count 0-3) when performing a neuromuscular block in pediatric patients aged 3 to 18 years undergoing strabismus surgery under general anesthesia can reduce the incidence of the oculocardiac reflex.

Condition or Disease	Intervention/Treatment	Phase
Strabismus	Other: moderate to deep neuromuscular blockade Other: shallow to minimal neuromuscular blockade	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Effect of the Deep Neuromuscular Block on the Refraction and the Oculocardiac Reflex During Strabismus Surgery in Pediatric Patients - a Prospective Randomized Controlled Trial

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: block group Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3, post-tetanic count > 1) Rocuronium (intravenous, 1.0 mg/kg)	Other: moderate to deep neuromuscular blockade Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3 count, post-tetanic count > 1) Rocuronium (intravenous, 1.0 mg/kg at induction period)
Active Comparator: control group Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count < 0.9) Rocuronium (intravenous, 0.3 mg/kg)	Other: shallow to minimal neuromuscular blockade Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count < 0.9) Rocuronium (intravenous, 0.3 mg/kg at induction period)

Arm

Intervention/Treatment

Experimental: block group

Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3, post-tetanic count > 1) Rocuronium (intravenous, 1.0 mg/kg)

Other: moderate to deep neuromuscular blockade

Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3 count, post-tetanic count > 1) Rocuronium (intravenous, 1.0 mg/kg at induction period)

Active Comparator: control group

Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count < 0.9) Rocuronium (intravenous, 0.3 mg/kg)

Other: shallow to minimal neuromuscular blockade

Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count < 0.9) Rocuronium (intravenous, 0.3 mg/kg at induction period)

Outcome Measures

Primary Outcome Measures

The incidence of grade 2 or greater oculocardiac reflex (induced) [During induced oculocardiac reflex test by ophthalmologists]
> 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle

Secondary Outcome Measures

The incidence of grade 1 oculocardiac reflex (induced) [During induced oculocardiac reflex test by ophthalmologists]
< 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle
The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery) [During general anesthesia for strabismus surgery (within 2 hour)]
> 20% reduction in heart rate during strabismus surgery
The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery) [During general anesthesia for strabismus surgery (usually within 2 hour)]
< 20% reduction in heart rate during strabismus surgery
Number of times Rescue IV Atropine has been used for oculocardiac reflex [During general anesthesia for strabismus surgery (within 2 hour)]
Number of times Rescue IV Atropine has been used (0.02mg/kg) for oculocardiac reflex
The incidence of hypotension [During general anesthesia for strabismus surgery (within 2 hour)]
The incidence of hypotension, defined as a drop to 20% or more of baseline mean blood pressure
Postoperative nausea/vomiting [From extubation to post-anesthesia care unit stay (within 1 hour)]
Presence of postoperative nausea/vomiting as assessed in the recovery room

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pediatric patients between the ages of 3 and 18 who are American Society of Anesthesiologists physical classification (ASA) I, II, or III scheduled for strabismus surgery under general anesthesia.

Exclusion Criteria:

Patients with underlying cardiovascular disease
Patients with preoperative electrocardiograms showing conduction disturbances
Patients with neuromuscular disease
Any other patient who, in the opinion of the investigator, is not a good candidate for the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Young-Eun Jang, Clinical Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05882643

Other Study ID Numbers:

H-2303-079-1412

First Posted:

May 31, 2023

Last Update Posted:

Jun 2, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Strabismus

Iodine

Study Results

No Results Posted as of Jun 2, 2023